The following data is part of a premarket notification filed by Beijing Lead Beauty S & T Co., Ltd with the FDA for Diode Laser Hair Removal Machine.
| Device ID | K192735 |
| 510k Number | K192735 |
| Device Name: | Diode Laser Hair Removal Machine |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Lead Beauty S & T Co., Ltd 202, No.5 Workshop, No.1 Caida 3rd Road Nancai Shunyi Distri Beijing, CN 101300 |
| Contact | Jiao Zhang |
| Correspondent | Diana Hong Mid-Link Consultinf Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-04-03 |